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(12) United States Patent (10) Patent No.: US 9,023,394 B2 Andersen Et Al

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(12) United States Patent (10) Patent No.: US 9,023,394 B2 Andersen Et Al USOO9023394B2 (12) United States Patent (10) Patent No.: US 9,023,394 B2 Andersen et al. (45) Date of Patent: *May 5, 2015 (54) FORMULATIONS AND METHODS FOR THE 4,330,338 A 5, 1982 Banker CONTROLLED RELEASE OF ACTIVE DRUG 4.389,393 A 6, 1983 Schor et al. 4.404,183 A 9, 1983 Kawata et al. SUBSTANCES 4,449,983 A 5/1984 Cortese et al. 4,503,067 A 3, 1985 Wiedemann et al. (71) Applicant: Egalet Ltd., London (GB) 4,686,212 A 8, 1987 Ducatman et al. 4,824,675 A 4/1989 Wong et al. (72) Inventors: Christine Andersen, Vedbaek (DK); 4,844,984 A 7, 1989 Eckenhoffetal. 4,873,080 A 10, 1989 Bricklet al. Karsten Lindhardt, Haslev (DK); Jan 4,892,742 A 1, 1990 Shah Martin Oevergaard, Frederikssund 4,898,733. A 2f1990 DePrince et al. (DK); Louise Inoka Lyhne-versen, 5,019,396 A 5/1991 Ayer et al. Gentofte (DK); Martin Rex Olsen, 5,068,112 A 11/1991 Samejima et al. Holbaek (DK); Anne-Mette Haahr, 5,082,655 A 1/1992 Snipes et al. 5,102,668 A 4, 1992 Eichel et al. Birkeroed (DK); Pernille Kristine 5,213,808 A 5/1993 Bar Shalom et al. Hoeyrup Hemmingsen, Bagsvaerd 5,266,331 A 11/1993 Oshlack et al. (DK) 5,281,420 A 1/1994 Kelmet al. 5,352.455 A 10, 1994 Robertson (73) Assignee: Egalet Ltd., London (GB) 5,411,745 A 5/1995 Oshlack et al. 5,419,917 A 5/1995 Chen et al. 5,422,123 A 6/1995 Conte et al. (*) Notice: Subject to any disclaimer, the term of this 5,460,826 A 10, 1995 Merrill et al. patent is extended or adjusted under 35 5,478,577 A 12/1995 Sackler et al. U.S.C. 154(b) by 0 days. 5,508,042 A 4/1996 OShlack et al. 5,520,931 A 5/1996 Persson et al. This patent is Subject to a terminal dis 5,529,787 A 6/1996 Merrill et al. claimer. 5,549,912 A 8, 1996 OShlack et al. 5,593,.695 A 1/1997 Merrill et al. (21) Appl. No.: 13/928,135 (Continued) (22) Filed: Jun. 26, 2013 FOREIGN PATENT DOCUMENTS (65) Prior Publication Data DE 10223844 12/2003 US 2013/02878.49 A1 Oct. 31, 2013 DE 202006O14131 1, 2007 (Continued) Related U.S. Application Data OTHER PUBLICATIONS (63) Continuation of application No. 12/823,067, filed on Jun. 24, 2010, now Pat. No. 8,563,038. Haahr et al. (Poster—Drug abuse resistant, controlled release using Egalet dosage units. Proceedings of the 34th annual Meeting Expo (60) Provisional application No. 61/219,817, filed on Jun. sition of the Controlled Release Society Jul. 7-11 2007).* 24, 2009. Katikaneni et al. (International Journal of Pharmaceutics 123 pp. 119-125 1995).* (30) Foreign Application Priority Data Notification of Transmittal of the International Search Report and the Written Opinion of the International Searching Authority issued Jul. Jun. 24, 2009 (DK) ................................. 2009 OO782 8, 2008 in International Application No. PCT/DK2008/000016. International Preliminary Reporton Patentability issued Jul. 16, 2009 (51) Int. Cl. in corresponding International Application No. PCT/DK2008/ A6 IK9/20 (2006.01) 000016, now WO 2008/086804. A6 IK3I/485 (2006.01) (Continued) A6 IK 9/28 (2006.01) (52) U.S. Cl. CPC ............. A61 K9/2086 (2013.01); A61 K3I/485 Primary Examiner — Anoop Singh (2013.01); A61 K9/28 (2013.01); A61 K9/2072 Assistant Examiner — Anna Falkowitz (2013.01) (74) Attorney, Agent, or Firm — Foley & Lardner LLP (58) Field of Classification Search CPC. A61 K31/485; A61 K9/2072: A61 K9/2086; A61 K9/28 (57) ABSTRACT USPC ........................... 424/486, 468; 514/282, 411 See application file for complete search history. Controlled release formulations and methods for preparing controlled release formulations for delivery of active drug (56) References Cited substances are described herein. The formulations described herein may be employed to produce pharmaceutical compo U.S. PATENT DOCUMENTS sitions, such as controlled release dosage forms, adjusted to a 2,685,553 A 8, 1954 Carroll et al. specific administration scheme. 3,835,221 A 9, 1974 Fulberth et al. 3,957,523 A 5, 1976 Ohno et al. 4,034,758 A 7, 1977 Theeuwes 38 Claims, 15 Drawing Sheets US 9,023,394 B2 Page 2 (56) References Cited 7,270,831 B2 9, 2007 Oshlack et al. 7,332, 182 B2 2, 2008 Sackler U.S. PATENT DOCUMENTS 7,399,488 B2 T/2008 Hirsh et al. 7,419,686 B2 9, 2008 Kaiko et al. 5,609,885 3, 1997 Rivera et al. 7,476,402 B2 1/2009 Kumar et al. 5,614,218 3, 1997 Olsson et al. 7,510,726 B2 3, 2009 Kumar et al. 5,618,560 4, 1997 Bar-Shalom et al. 7,510,727 B2 3, 2009 Oshlack et al. 5,656,291 8, 1997 Olsson et al. 7,514,100 B2 4/2009 Oshlack et al. 5,656,295 8, 1997 Oshlack et al. 7,666,337 B2 2, 2010 Yang et al. 5,667,805 9, 1997 Merrill et al. 7,749,542 B2 T/2010 Kaiko et al. 5,672,360 9, 1997 Sackler et al. 7,771,707 B2 8, 2010 Hirsh et al. 5,741,524 4, 1998 Staniforth et al. 7,776,314 B2 8, 2010 Bartholomaus et al. 5,866, 161 2, 1999 Childers et al. 7,790,215 B2 9, 2010 Sackler et al. 5,866, 164 2, 1999 Kuczynski et al. 7,842,307 B2 11, 2010 Oshlack et al. 5,869,097 2, 1999 Wong et al. 7,846,476 B2 12/2010 Oshlack et al. 5,879,705 3, 1999 Heafield et al. 7,883,722 B2 2, 2011 Bar-Shalom 5,882,682 3, 1999 Rork et al. 7,883,772 B2 2, 2011 Pourdeyhimi et al. 5,914, 131 6, 1999 Merrill et al. 7,897,080 B2 3, 2011 Yang et al. 5.948,787 9, 1999 Merrill et al. 7,906, 143 B1 3, 2011 Odidi et al. 5,952,005 9, 1999 Olsson et al. 7,943,174 B2 5, 2011 Oshlack et al. 5,958,452 9, 1999 Oshlack et al. 7.972,624 B2 T/2011 Li et al. 5,968,551 10, 1999 Oshlack et al. 7,981,439 B2 T/2011 Kumar et al. 6,046,177 4, 2000 Stella et al. 8,017,148 B2 9, 2011 Sackler 6,066,339 5, 2000 Stark et al. 8,017,150 B2 9, 2011 Yang et al. 6,077,533 6, 2000 Oshlack et al. 8,029,822 B2 10, 2011 Faour et al. 6,077,538 6, 2000 Merrill et al. 8,075,872 B2 12/2011 Arkenau-Maric et al. 6,103.261 8, 2000 Chasin et al. 8, 101,630 B2 1, 2012 Kumar et al. 6,117,453 9, 2000 Seth et al. 8, 105,631 B2 1, 2012 Kaiko et al. 6,143,328 11, 2000 Heafield et al. 8,114,383 B2 2, 2012 BartholomAUs et al. 6,183,778 2, 2001 Conte et al. 8,114,384 B2 2, 2012 Arkenau et al. 6,225,343 5, 2001 Behlet al. 8,133,507 B2 3, 2012 Yum et al. 6,245,351 6, 2001 Nara et al. 8,142,811 B2 3, 2012 Oshlack et al. 6,245,357 6, 2001 Edgren et al. 8, 147,870 B2 4, 2012 Yum et al. 6,267.981 T/2001 Okamoto et al. 8,153,152 B2 4, 2012 Yum et al. 6,267,985 T/2001 Chen et al. 8,168.217 B2 5, 2012 Yum et al. 6,277,384 8, 2001 Kaiko et al. 8,173,152 B2 5, 2012 Crowley et al. 6,284.274 9, 2001 Merrill et al. 8, 182,836 B2 5, 2012 Mehta 6,294,195 9, 2001 Oshlack et al. 8, 192,722 B2 6, 2012 Arkenau-Maric et al. 6,348,216 2, 2002 Kushla et al. 8,231,898 B2 T/2012 Oshlack et al. 6,375,957 4, 2002 Kaiko et al. 8,246,986 B2 8, 2012 Cruz et al. 6,383,471 5, 2002 Chen et al. 8,309,060 B2 11, 2012 Bartholomaus et al. 6,395,299 5, 2002 Babich et al. 8.323,889 B2 12/2012 Arkenau-Maric et al. 6,399,096 6, 2002 Miller et al. 8,329.720 B1 12/2012 King et al. 6,403,579 6, 2002 Heller 8,337,888 B2 12/2012 Wright et al. 6,451,848 9, 2002 Behlet al. 8.338,444 B1 12/2012 King et al. 6.458,772 10, 2002 Zhou et al. 8,354,124 B2 1, 2013 Yum et al. 6,458,824 10, 2002 Iwata et al. 8,361,499 B2 1, 2013 Oshlack et al. 6,475,494 11, 2002 Kaiko et al. 8,367,693 B1 2, 2013 King et al. 6,482.437 11, 2002 Debregeas et al. 8,372.432 B2 2, 2013 Han et al. 6,488,962 12, 2002 Berner et al. 8,377,453 B2 2, 2013 Han et al. 6,488.963 12, 2002 McGinity et al. 8,383,152 B2 2, 2013 Jans et al. 6,491,945 12, 2002 Childers et al. 8,383,154 B2 2, 2013 Bar-Shalom 6,517,866 2, 2003 Am Ende et al. 8,383,155 B2 2, 2013 Bar-Shalom 6,534,085 3, 2003 Zeligs 8,389,007 B2 3, 2013 Wright et al.
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